The European Medicines Agency said it may become more difficult for UK firms to have GMP non-compliance statements lifted following Brexit. Source: International Pharmaceutical Regulatory Monitor
A New Jersey federal court ruled that a Taiwanese firm infringed on patents held by Maryland-based drugmaker Supernus. Source: International Pharmaceutical Regulatory Monitor
New guidance from the UK’s National Institute of Health and Care Excellence links the cost-effectiveness of different bisphosphonate medications for osteoporosis with a patient’s 10-year risk of bone fractures. Source:…
The European Medicines Agency invited stakeholders to comment on a planned guidance on nonclinical development of radiopharmaceutical products. Source: International Pharmaceutical Regulatory Monitor
The FDA and the European Medicines Agency released a draft joint plan to support the development of pediatric treatments for Gaucher disease — an approach the agencies say can apply…
Data integrity, recordkeeping and drug trial oversight violations feature in the UK Medicines and Healthcare products Regulatory Agency’s latest report on good clinical practice inspections. Source: International Pharmaceutical Regulatory Monitor
The European Medicines Agency is provisionally restricting the use of the multiple sclerosis medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that has failed to respond to certain…
The Australian Therapeutic Goods Administration issued an industry guidance proposing to quickly approve certain types of low-risk variations to registered medicines without requiring evaluation, allowing sponsors to implement the changes…
The U.K. is planning to move Roche’s Kadcyla (trastuzumab emtansine) into the NHS’s routine funding programs later this summer, following guidance from the National Institute for Health and Care Excellence…
The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and…